Subutex 0.4mg sublingual tablets

Land: Storbritannien

Sprog: engelsk

Kilde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiv bestanddel:

Buprenorphine hydrochloride

Tilgængelig fra:

Indivior UK Ltd

ATC-kode:

N02AE01

INN (International Name):

Buprenorphine hydrochloride

Dosering:

400microgram

Lægemiddelform:

Sublingual tablet

Indgivelsesvej:

Sublingual

Klasse:

Schedule 3 (CD No Register)

Recept type:

Valid as a prescribable product

Produkt oversigt:

BNF: 04070200; GTIN: 5054792000316

Indlægsseddel

CUSTOMER INFO:
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0000000
Buprenorphine
Treatment
Subutex
0.4mg, 2mg & 8mg
N/A-
TRIND426870
UNDER NO CIRCUMSTANCES SHOULD
THIS ARTWORK BE ALTERED WITHOUT
PRIOR PERMISSION FROM TRIDENT.
Please note that any low resolution paper Canon colour
copies associated with this job should be referred to for
content, layout and colour separation only.
STUDIO USE ONLY
v1.0
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Essentra Packaging (Bradford, UK)
Sub-Lflt-D0081679-340x298mm
TR1909767
Paper White
UK
24/08/20
C
SM01105
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- JG - 24/08/20 10:11:05
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PACKAGE LEAFLET:
INFORMATION FORTHE USER
SUBUTEX®0.4 MG, 2 MG AND 8 MG
SUBLINGUAL TABLETS
buprenorphine
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU
START TAKING THIS MEDICINE BECAUSE IT
CONTAINS IMPORTANT INFORMATION FOR YOU.
•
Keep this leaflet.You may need to read it
again.
•
If you have any further questions, ask your
doctor or pharmacist.
•
Thi

Produktets egenskaber

SUMMARY OF PRODUCT CHARACTERISTICS
1
NAME OF THE MEDICINAL PRODUCT
Subutex 0.4 mg sublingual tablets
Subutex 2 mg sublingual tablets
Subutex 8 mg sublingual tablets
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Subutex 0.4 mg sublingual tablets
Each tablet contains 0.4 mg buprenorphine (as buprenorphine
hydrochloride).
Excipient(s) with known effect: lactose
For the full list of excipients, see section 6.1
Subutex 2 mg sublingual tablets
Each tablet contains 2 mg buprenorphine (as buprenorphine
hydrochloride).
Excipient(s) with known effect: lactose
For the full list of excipients, see section 6.1
Subutex 8 mg sublingual tablets
Each tablet contains 8 mg buprenorphine (as buprenorphine
hydrochloride).
Excipient(s) with known effect: lactose
For the full list of excipients, see section 6.1
3
PHARMACEUTICAL FORM
Sublingual tablet
Subutex 0.4 mg sublingual tablets
Uncoated oval white flat bevelled edged tablet, nominal dimensions 8
mm x 4 mm, debossed
with “04” on one side.
Subutex 2 mg sublingual tablets
Uncoated oval white flat bevelled edged tablet, nominal dimensions 10
mm x 5 mm, debossed
with “B2” on one side.
Subutex 8 mg sublingual tablets
Uncoated oval white flat bevelled edged tablet, nominal dimensions 14
mm x 7 mm, debossed
with “B8” on one side.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Substitution treatment for opioid drug dependence, within a framework
of
medical, social and psychological treatment.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Prior to starting treatment with opioids, a discussion should be held
with patients to put in
place a strategy for ending treatment with buprenorphine in order to
minimise the risk of
addiction and drug withdrawal syndrome (see section 4.4). The decision
to maintain a patient
on a long-term opioid prescription should be an active decision agreed
between the clinician
and patient with review at regular intervals (usually at least
three-monthly, depending on
clinical progress).
Posology
Treatment with Subutex sublingual tablets is intended for use